The only clinical outsourcing platform for the biotech, pharma and medical device companies in Israel

Transcription

1 The only clinical outsourcing platform for the biotech, pharma and medical device companies in Israel Speakers in 2018 Sachi Norman, Chief Medical Officer, Life Bond Ayelet Levanon, Associate Director, Global Clinical Operations, Janssen Illana Gozes, Chief Science Officer, Coronis Neurosciences Liora Bosch, Bio-Statistician and EDC expert, Omrix Biopharmaceuticals, Johnson & Johnson Marina Weisflender, Head of Clinical & Regulatory Affairs, Amorphical Pnina Strauss-Levy, VP Clinical & Regulatory Affairs, Intec Pharmaceuticals Nahum Ferera, Chief Science Officer, EyeYon Medical Adar Shani, VP Clinical & RA, Nuvo Group Tali Amir-Azulay, Director of Operations, Neuroderm Moshe Golan, President and CEO, 3QBD Keren David-Zarbiv, Director of Clinical Affairs, MediWound Dror Chevion, CEO, Concenter Bio Pharma Sharon Castro, Director of Clinical Trials, Kamada Liran Korine, Director of Clinical Affairs, ElMindA Tami Yardeni-Nadiv, COO, Neuroderm Stephen Marx, CEO, Marx Technologies Ron Nitzan, VP QA/RA, Keystone Heart Vardit Segal, VP Clinical & Regulatory Affairs, Allium Medical Bernard Green, CSO, Semorex Inc Nitza Shoham, VP, Clinical & RA, Valtech Cardio Irit Glicko-Kabir, Senior Director Clinical Development, BioLineRx Israel Citron, VP QA & RA, Aspect Imaging Catherine Ela, Head of the Clinical Trial Department, Ministry of Health Dr. Yafit Stark, Vice President, Chief Clinical Officer and Head of Oncology, Emerging Therapeutic Areas & Biogenetics Innovative R&D, Teva Sharon Shachar, Director of Quality & Regulation, InspireMD Further Information For sponsorship opportunities please contact: Alexander O Leary AlexanderOLeary@arena-international.com Tel: For program enquiries please contact: Lucy Tanner Lucy.Tanner@arena-international.com Tel:

2 Programme Day One 20 th March :45 Registration and Refreshments 8:20 Chairman s Opening Remarks 8:30 Keynote Presentation Home Advantage: Assessing Israel s competitive landscape to underpin and sustain your competitive advantage Evaluating the competitive landscape within Israeli industry to illustrate growing competitive nature of sector, highlighting key R&D gaps to capitalise upon Illustrating latest developments within industry to determine Israel s home competitive advantage to explore how entrepreneurism can be further leveraged Establishing areas that quickly becoming saturated to explore opportunities for unique products Reviewing importance of differentiation techniques within both product and process innovation to increase product value and market positioning Highlighting key opportunities within patient recruitment within Israel to assess benefits of clinical trials within the country Dr. Yafit Stark, Vice President, Chief Clinical Officer and Head of Oncology, Emerging Therapeutic Areas & Biogenerics Innovative R&D, Teva 9:00 Session reserved for Boston Biomedical Association Sourcing optimal vendors to enable accurate and successful trials 9:30 Fail to Prepare, Prepare to Fail: Exploring key preparation considerations of outsourcing clinical trials to ensure seamless procedures Investigating outsourcing streams to establish vertically integration opportunities, in order to cut costs Evaluating clinical trial processes to ensure optimal resource allocation Determining difficulties of procuring vendors to establish demands for flexible budgets and timelines Illustrating mapping techniques to ensure operations achieve deadlines Highlighting changing regulations and guidelines between countries to prepare for challenges in clinical trials Sharon Shachar, Director of Quality and Regulation, InspireMD 10:00 Agenda Highlight

3 Q&A session with the Ministry of Health Detailing regulatory changes within the industry to assess changing needs and direction of processes, to ensure compliant procedures within clinical trials 10:00 10:15 Outlining new regulations to explore impacts of changing requirements and guidelines on the industry to allow better preparation Highlighting implications of implemented changes to forecast increasing pressures and mitigate concerns Exploring outcomes for non-compliant activities to determine impact on drug development and company reputation 10:15 10:30 Q&A Question from the audience for the Ministry of Health Catherine Ela, Head of the Clinical Trial Department, Ministry of Health 10:30 Networking and Refreshments 11:00 Panel Discussion Attaining an Optimal Fit: Evaluating vendor procurement and relationships to enable successful studies Identifying internal resources and establishing key company competencies, to explore areas in need of outsourcing Illustrating optimal partnerships that align with company culture to ensure seamless clinical trial operations Evaluating how exceptional partnerships ensure optimal collaboration to ensure long lasting and successful relationships Exploring best practises in environment scanning to ensure vendor partnerships that best fit your operations Discussing implications of poor Sponsor-CRO planning to highlight implications on vendor relationships Sharon Shachar, Director of Quality and Regulation, InspireMD Keren David-Zarbiv, Director of Clinical Affairs, MediWound Ayelet Levanon, Associate Director - Global Clinical Operations, Janssen 11:30 Session reserved for PRA Health Sciences International procurement of clinical trials and foreign studies

4 12:00 Part One 12:00-12:20 Discussing international studies in theory to provide a deep-seated overview of key benefits in foreign markets Assessing fundamental differences in outsourcing local vs international studies to create an appreciation for varying levels of bureaucratic processes and contrasting challenges Illustrating operational differences with Europe and USA to evaluate how to ensure timely studies Highlighting pivotal pros and cons of international studies to underpin efficiency difficulties and best operational techniques Investigating management inefficiencies between countries to underpin advantages of outsourcing abroad Illustrating outsourcing contracts with CROs in China to underpin opportunities and challenges and gauge a greater understanding of key cost and time implications on drug development procedures Irit Glicko-Kabir, Senior Director Clinical Development, BioLineRx Part Two 12:20 12:40 Evaluating international studies in practice to establish successful foreign clinical trials Highlighting cultural differences to ensure optimal vendor management techniques Assessing key preparation steps to ensure that optimal positioning with CROs is achieved to ensure maximum efficiency Exploring management techniques to secure collection of accurate data in agreed time frame Determining crucial communication techniques with principal investigators to ensure responsibility and duties are met Nahum Ferera, Chief Science Officer, EyeYon Medical 12:40 12:55 International study Q&A with the audience Irit Glicko-Kabir, Senior Director Clinical Development, BioLineRx Nahum Ferera, Chief Science Officer, EyeYon Medical 12:55 Lunch and Networking Key vendor management techniques and tools 14:00 Panel Discussion Cool, Cohesive and Controlled: Establishing control retention methods to place upon CROs to ensure timely clinical trials Highlighting biggest hardships and conflicts of interest when partnering with CROs, to alleviate clashes

5 Evaluating implications of conflicts to illustrate ramifications on financial resources Assessing how best to implement payment milestones and invoice strategies to establish control of partnership Exploring options and benefits of outsourcing audits to secure disciplined trials Investigating varying needs of control over different vendors to ensure superior resource allocation Adar Shani, VP Clinical & RA, Nuvo Group Pnina Strauss-Levy, VP Clinical & Regulatory Affairs, Intec Pharmaceuticals Israel Citron, VP QA & RA, Aspect Imaging 14:30 Session reserved for Event Sponsor 15:00 Mother of all Management Methods: Establishing key performance metrics to ensure timely studies within budget Highlighting critical issues with CROs who over promise and under deliver to underpin the need for sharper management techniques Evaluating best utilisation of performance measures to enhance CRO productivity and ensure efficient operations of studies Determining events if stringent mechanisms are not applied to studies to appreciate implications and benefits of metrics Illustrating major risks of poor performance metrics strategies to ensure collaborative studies Highlighting how performance measurement will improve relationships with CROs to enable best sponsor-vendor relationships Irit Glicko-Kabir, Senior Director Clinical Development, Biolinerx 15:30 Afternoon refreshments and networking 16:00 Communication Conundrums: Establishing how best to communicate with your CRO to ensure efficient managerial methods to secure successful clinical trials Highlighting excellent sponsor-cro communication strategies to investigate levels of resource allocation Illustrating transparent communication techniques that will foster mutual sponsor- CRO trust, to enable close collaboration within studies and long lasting relationships Exploring various channels of communication to underpin united strategies that ensure clinical trials are timely Investigating effects of poor communication strategies to mitigate negative impacts on CRO relationships Determining implications of too much communication to establish effect on timeframes

6 Tali Amir-Azulay, Director of Operations, Neuroderm 16:30 Managing Multiple CROs: Exploring multi CRO management to ensure successful clinical trials Discussing wide ranges of activities that can be outsourced to lean operations Exploring multi-vendor management strategies to administer better control of procedures Revisiting changes within regulatory environment to underpin forthcoming challenges and opportunities of managing EU and USA vendors Evaluating placements of resources to ensure stringent process in an affordable and timely manner Recalling top communication techniques to ensure efficient portfolio management and reap time efficiencies Keren David-Zarbiv, Director of Clinical Affairs, MediWound 17:00 Difficult Decisions: Appraising outsourcing models to ensure cohesive alignment with business needs Exploring outsourcing models to create an appreciation for benefits of fully outsourced vs partially outsourced activities Highlighting implications of miscalculated outsourcing models to ensure negative threats upon time and money are mitigated Reviewing core competencies of sponsors to examine outsource full-service CROs or multiple third parties, to ensure a low cost business strategy Tami Yardeni-Nadiv, COO, Neuroderm 17:30 Chairman s summation and close of day one Programme Day Two 21 st March :00 Registration and Refreshments 8:20 Chair s Opening Remarks Chair s Opening Remarks Medical Device Stream Biotech Stream 8:30 Panel Discussion: Proving guidance through regulations to evaluate implications of new requirements to ensure compliant studies for Medical Devices Establishing clarification over Panel Discussion: Exploring contrasting characteristics between sponsors to ensure successful studies to clarify ambiguous variables Assessing varying attributes between drug development companies to explore

7 integration of new ISO13485 regulations to evaluate a common understanding between regulators and industry Establishing regulatory changes to new product clinical reviews to underpin future challenges in outsourcing studies Highlighting biggest changes to industry quality assurance practices to underpin best methods to meeting new regulatory requirements Illustrating processes which will need changing to determine economic implications on resource allocation, budget constraints and potential funding needs, as well as operations to ensure compliant systems Examining implementation of new operations to ensure legitimate studies and enable continued success in manufacture options in size of CRO sourced Exploring small contractors to illustrate potential needs for tick transferring processes Investigating impacts of tick transfer processes to determine value of small vendors and mitigate inefficiencies in new product development Determining crucial management techniques for large CROs to ensure they do not take advantage of sponsors Exploring options to integrate both a small and large CRO, to utilise their expertise for different services and implement a competitive business strategy Illana Gozes, Chief Science Officer, Coronis Neurosciences Dror Chevion, CEO, Concenter Bio Pharma Irit Glicko-Kabir, Senior Director Clinical Development, Biolinerx 9:00 Complications with CE: Highlighting FDA enforcements for attaining CE marked products, to establish best practices in achieving certification Highlighting stringent enforcements from Medical Device Regulators to create an awareness for increasingly arduous and lengthy obstacles Assessing demands from authorities and ethics committees when conducting new Medical Device studies to appreciate crucial difficulties in achieving CE certified products Illustrating technical and documentation difficulties to mitigate impact on timeframes Perils of Small Companies: Lessons Learnt from a biotech perspective; where, what and how to outsource CROs efficiently Assessing niche drug development studies to create an awareness and appreciation for tight, strategic alignment with CROs that compliment your business needs Highlighting the need for a vendor that truly understands your drug development concept to ensure a timely and accurate study Evaluating implications upon quality if poorly suited CRO is contracted, to establish strategic methods of outsourcing vendors Creating an awareness of un-kept

8 Discussing timelines to evaluate subsequent increased timespan of processes with the MDR and financial risk Underpinning best methods to get FDA approval for new medical to enable an efficient entry to market Vardit Segal, VP Clinical & Regulatory Affairs, Allium Medical promises from Vendors to highlight lessons learnt and best CRO recruitment strategies. Discussing specialist CROs to illustrate best fit in terms of equipment and expertise Stephen Marx, CEO, Marx Technologies 9:30 Partnering Up: Reviewing medical device studies to evaluate need for product expertise for successful trials Discussing needs for specialist medical device CROs to underpin key efficiency opportunities within clinical trial studies Highlighting key benefits of utilising specialist vendor to ensure timely procedures Illustrating fundamental CRO sourcing techniques to secure the right partner and enable specialised studies Investigating specialist expertise to highlight implications on accuracy of medical trial studies if not sourced diligently Evaluating stringent CRO recruitment strategies to effectively understand truths behind pitches, to ensure promises are kept throughout medical device studies Sachi Norman, Chief Medical Officer, Life Bond Not EU Again: Identifying key opportunities and mitigating challenges in new EU regulations to alleviate impact on budgets Highlighting key changes in regulatory guidelines within European confidentiality directives to better prepare for future plausible challenges Assessing implications new regulations could bring in attaining FDA approval to mitigate further strain on budgets and timespans Illustrating strategies to ensure protocols achieve FDA approval in light of new directives, to efficiently mitigate financial risk and shorten process of ratification Evaluating benefits of incorporating authorities within studies to enable transparent procedures, to ensure seamless clinical development procedures Revisiting outsourcing models to determine benefits of procuring protocol experts and ensure compliant studies Marina Weisflender, Head of Clinical & Regulatory Affairs, Amorphical 10:00 Session reserved for Event Sponsor Session reserved for Event Sponsor 10:30 Morning Refreshments and Networking

9 Medical Device Stream 11:00 Quality vs Costs: Exploring needs to strike optimal balance between quality and cost of outsourcing clinical trials to achieve first-rate business strategies Highlighting increasing need for studies of highest quality to enable seamless authorisation of drug developments Discussing results of clinical trials against budget restricting to create greater appreciations for quality and accurate data collection and ensure accreditation of drug development Evaluating financial risk against quality need to establish an optimal balance that will enable visible resource allocation strategies Illustrating outsourcing opportunities that enhance quality of studies to ensure accurate data Investigating relationships between implementing increased quality standards and timeframes to ensure efficient and effective clinical trials Biotech Stream Shall we or Shan t we? Outlining blessings and drawbacks of outsourcing clinical trials within Israel to assess degree of complementation Exploring Israel s varied portfolio of services to evaluate opportunities for clinical trials Assessing changes in regulations to highlight time impediments and financial risk on studies Examining diversified patient population within Israel to establish key quality benefits of conducting trials within home country Evaluating benefit and pitfalls of managing vendors in close proximity Dror Chevion, CEO, Concenter Bio Pharma Nitza Shoham, VP, Clinical & RA, Valtech Cardio 11:30 Quality Qualms: Exploring need for quality within medical device studies to ensure controlled timeframes Assessing early stage development of medical devices to explore key product strategy considerations that ensure optimal outsourcing studies Discussing needs for increased Exploring methods to best manage third parties within investigator integrated researched clinical trials Assessing best methods to effectively overseeing an investigator initiated trial Illustrating implications of poor management of trials to highlight lessons learnt during procedures Exploring third party investigators,

10 short-term flexibility in medical device advancement to enable focused long-term approach to clinical trials Highlighting benefits of specialist vendors to establish top quality studies Revisiting outsourcing strategies that enable partnerships with top quality CROs to mitigate financial risk Appreciating quality hindrances during clinical trials, such as issues with patient recruitment, to establish realistic timelines and budgets especially physician to illustrate motivational techniques, to ensure timely studies and quick route to market Determining whether sponsorship is a better option, to establish if this could result in more timely and efficient studies over government funded research studies Establishing changes in MDR to evaluate impacts upon investigator integrated trials to forecast plausible challenges and changes in guidance Illana Gozes, Chief Science Officer, Coronis Neurosciences Ron Nitzan, Vice President of Quatliy Assurance and Regulatory Affairs, Keystone Heart 12:00 Staff Motivation: Establishing strategies in which to drive staff to control the speed of clinical trials Highlighting areas of inefficiencies during clinical trials to underpin increasing need to motivate staff to ensure timely studies Assessing management techniques to motivate staff to enable timely studies Painting the bigger picture to illustrate constraints of patient recruitment within clinical trials to reassess and set realistic timelines and budgets Pinpointing areas of flexibility within medical centres to highlight potential for increased procedure efficiencies Exploring key methods of collaboration with physicians, to Collaboration Capacity: Highlighting medical centre collaboration strategies to ensure accurate and credible studies Illustrating mechanisms to co-ordinate medical centres during trials to appreciate how to escalate on a national level and help mitigate issues of internal politics within procedure Assessing duties of physicians within medical centres to highlight their varying pressures, and attain a high level of empathy Exploring best methods for collaborating with physicians to underpin strategies in which to motivate them on studies Detailing key channels to adopt when communicating with physicians to further inspire them on your study to control speed of clinical trial Evaluating implications of demotivated staff to illustrate small management tools can reap long term benefits

11 highlight communication techniques that motivate staff to ensure a cohesive and accurate study Sharon Castro, Director of Clinical Trials, Kamada Liran Korine, Director of Clinical Affairs, ElMindA 12:30 Negotiating with CROs: Establishing top techniques to secure cost effective clinical trials Highlighting growing needs for superior negotiation techniques with vendors to secure improved deals and mitigate financial risk Illustrating benefits and pitfalls of solid negotiation methods to underpin the sweet spot and mitigate hostile relationships Discussing variations between CRO characteristics to create an appreciation for different negotiation strategies, to secure top deals Exploring crucial negotiation strategies that will ensure superior arrangements with CROs to enable smooth procedures Assessing key repercussion on commitment intention of CROs to illustrate subsequent gain of control over vendors to reap financial benefits Moshe Golan, President and CEO, 3QBD Once emerging, now falling: Assessing FDA crack down on India to evaluate implication upon drug development studies and underpin financial impacts Exploring FDA investigations into contractors to forecast plausible futures on sponsors who geographically outsource third parties from India Evaluating inspections to highlight likelihood of outcome, to assess the negative implications within quality when building relationships with CROs from India Highlighting FDA actions with Indian clinical trial processes and the pitfalls with their drug development studies to underpin key concerns Examining implications of folding, experienced and low cost outsourcers to illustrate effects on budgets and financial resource allocation Discussing new emerging markets, such as China, to determine their reliability and credibility as partners and assess outsourcing potential in line with business strategy 12:30 Lunch and Networking 13:30 Q&A with Investor Need my Money? Here s how you get it. A transparent view into key criteria investors seek when Pnina Strauss-Levy, VP Clinical & Regulatory Affairs, Intec Pharmaceuticals

12 13:30 13:45 Snippet from Investor Assessing key benchmarking tools utilised by investors and agencies to underpin bottom line investment criteria Analysing Israel s competitive landscape to detail how differentiation can be achieved, to deliver uniqueness and secure a competitive advantage Illustrating how new start-up companies can attain funding to help get product to market 13:15 13:30 Q&A Session with Investor Questions from the audience Israel Citron, VP QA & RA, Aspect Imaging 14:00 Q&A Session Financial Needs: A funding headache Assessing strategies to raise funds and attain investment to ensure product development and attain a crucial market position Assessing hardships of securing investment for developing new drugs explore implications on industry landscape Highlighting competition within the market for funding, to examine unique selling points of product to champion funding Evaluating different methods of acquiring funding, from EU sponsorship to building relationships with private agencies, to illustrate options within the sector Exploring methods to best convince an agency you are worth investment, to fast track development of your products Examining key lessons learnt from pitches to investment agencies to illustrate best and worst approaches to gaining funding Bernard Green, CSO, Semorex Inc 14:30 Session reserved for Event Sponsor 15:00 Afternoon Refreshments and Networking 15:30 Roundtables Break-out sessions to allow smaller groups to discuss the most pertinent themes of the event in finer and more case study-driven detail. Delegates should leave these sessions equipped with practical solutions to key challenges. RT1 Home Advantage: Determining where your true uniqueness lies to underpin competitive advantage

13 RT2 RT3 Data Management: To outsource or to vertically integrate? Assessing key resources and capabilities to underpin a data strategy that aligns with your key competencies Liora Bosch, Bio-Statistician and EDC expert, Omrix Biopharmaceuticals, Johnson &Johnson Lessons Learnt: Implications of micromanaging a CRO to evaluated key management techniques RT4 Negotiating with large CROs: Establishing top techniques to secure cost effective clinical trials to secure best deals 16:30 Chair s Closing Remarks and End of Conference